April 26, 17.25 PM IST || Pocket News Alert
~ First such therapy that will be made available for benefit of people with haemophilia A in India~
Chandigarh, 26 April 2016. Novo Nordisk, a leading player in haemophilia care, today launched NovoeightTM,(Antihemophilic Factor [Recombinant]) in India for use in the treatment and prevention of bleeding in people with haemophilia A (congenital factor VIII deficiency) across all age groups.1 It can also be used to prevent excessive bleeding in people with haemophilia A undergoing surgery.1
Congratulating Novo Nordisk India, Mads Bo Larsen, Corporate Vice President Business Area Gulf, India and Egypt said: “We are very excited about having reached this goal. Turoctocog alfa represents a new treatment alternative for people with haemophilia A and is one of the first important outcomes of the haemophilia research strategy we embarked upon about a decade ago. The approval of Novoeight™ marks an important step in offering a new alternative for people with haemophilia A, and demonstrates our commitment to haemophilia.”
Haemophilia is a chronic, inherited bleeding disorder that primarily affects males. People with haemophilia A are either missing or have a malfunctioning factor VIII protein, which is essential for proper blood clotting. People with haemophilia A have a tendency to bleed longer than most or to bleed internally into joints, muscles or organs because they are missing this clotting factor. To manage the disease and stop bleeding, people with haemophilia A must replace the missing factor VIII protein, which is accomplished by intravenous injection of the clotting factor
The active ingredient in NovoEight™ is turoctocog alfa, a B-domain truncated recombinant Antihemophilic Factor which is produced by third generation recombinant DNA technology.1 This means that it is prepared without the addition of any human or animal derived protein in the entire manufacturing process.1 In addition it undergoes a 5-step purification process which includes two dedicated viral clearance steps - a detergent treatment step for inactivation of enveloped viruses and nanofiltration with 20 nm pore size membranes that reduces infectivity due to prions and small non-enveloped viruses.1-3 This results in significant reduction in the risk of allergy or infections, otherwise present in currently marketed recombinant or plasma derived FVIII products in India.1-5
Speaking at the launch, Melvin D’souza, Vice President and General Manager, Novo Nordisk India Pvt Ltd. said: “For the last decade, Novo Nordisk is working towards improving lives of people with haemophilia through support to improved diagnosis, treatment and care. We offer a broad and innovative range of products to ensure that we are in the forefront of finding the next generation of medicines. With the launch of NovoeightTM that is manufactured by third generation recombinant DNA technology, this becomes first such therapy that will be made available for benefit of people with haemophilia A in India.”
Also present at the launch was Dr Cecil Ross, Vice President, Haemophilia Federation India. He said he was happy that Turoctocog alfa is another treatment option introduced by Novo Nordisk. “There must be more players in the market to benefit the wider haemophilia community. This is a new alternative in factor VIII treatment. It is based on the most advanced protein and purification technology and has been designed to expand reliability, safety and portability for people with haemophilia A.”
Dr Naresh, Chief of Haemophilia Day care centre, Maulana Azad Medical College New Delhi who was present at the launch said: “Turoctocog alfa bespeaks of Novo Nordisk's commitment to wider haemophilia community with the pioneering launch of this third generation recombinant clotting Factor VIII, a first in India.”
NovoeightTM offers enhanced portability and convenience as it comes with an intuitive device for reconstitution and advantage of highest storage temperature for the longest period of time (up to 300C for 9 months) compared with the marketed recombinant Factor VIII product in India.4 It can be kept at that temperature for up to 4 hours after reconstitution, and for up to 24 hours in the refrigerator (20C – 80C) giving it the longest post reconstitution storage time.1,4
About NovoeightTM
NovoEightTM contains human coagulation factor VIII (rDNA), turoctocog alfa, a glycoprotein that has the same structure as human factor VIII when activated. When infused into a haemophilia patient, NovoeightTM binds to endogenous von Willebrand factor in the patient’s circulation. This is essential for factor VIII to bring its desired action without premature degradation. Upon activation, NovoeightTM acts as a co-factor for activated factor IX, accelerating the conversion of factor X to activated factor X. Activated factor X converts prothrombin into thrombin. Thrombin then converts fibrinogen into fibrin and a clot can be formed.
In the clinical trials that were conducted to evaluate the safety and efficacy of NovoeightTM, none of the patients developed inhibitors that was confirmed in 213 previously treated patients with hemophilia A. Inhibitors are recognised complication of FVIII treatment in people with haemophilia A. The median annualized bleeding rate was 3.1 in 213 adults, adolescents, and children treated with NovoeightTM prophylaxis. Ninety-one percent of bleeds experienced by patients in these trials were controlled with 1 or 2 doses.
NovoeightTM is approved by the US FDA (October 2013) and the European Medicines Agency (November 2013) for the treatment and prevention of bleeding in patients with hemophilia A. Novoeight® also is approved in Japan (January 2014), Australia (January 2014), and Switzerland (February 2014), and recently approved by Central Drugs Standard Control Organisation, New Delhi, India.
About Haemophilia
Haemophilia is a genetic disorder. The most common type of haemophilia are haemophilia A and B. Haemophilia is classified according to the level of clotting factors in the blood. The symptoms of haemophilia vary depending on how severe the condition is, but the main sign is prolonged bleeding.
Haemophilia is diagnosed by testing a sample of your tissue or blood to look for signs of genetic mutation that causes haemophilia. Tests may be done before and during pregnancy and after child birth.
About Novo Nordisk
Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: haemophilia, growth disorders and obesity. Headquartered in Denmark, Novo Nordisk employs approximately 40,300 people in 75 countries and markets its products in more than 180 countries. For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn, YouTube